Cognitive Impairment (CI) Clinical Trial
Official title:
Evaluation of Rapid Cognitive Screening Tools for Detection of Cognitive Impairment in Older Surgical Patients: A Prospective Cohort Study - Detect CI Study
This is a prospective multicenter cohort study which will evaluate rapid (administration time ≤ 5 minutes) cognitive screening tools that can be administered preoperatively in older patients undergoing noncardiac surgery. Namely, our study will determine the diagnostic accuracy (sensitivity, specificity, and area under the curves [AUC]) of two rapid, easily administered cognitive screening tools: the Mini-Cog and the Ascertain Dementia 8-item Questionnaire (AD8) against the Montreal Cognitive Assessment (MoCA). Additionally, we will examine the prevalence of cognitive impairment (CI) in patients meeting the CI criteria by either the AD8, Mini-Cog, or MoCA and the prevalence of elevated levels of plasma biomarker of phosphorylated tau 181 (pTau181) and neurofilament-light chain (NfL) in the patients meeting the CI criteria. This study will target older patients from surgical offices and/or pre-admission clinics at Toronto General (TGH), Toronto Western (TWH), and Mount Sinai Hospital (MSH), Toronto, Ontario. The identification and recruitment of eligible patients will be a collaborative effort between the nurses, surgeons, anesthesiologists, and the research team. Written informed consent to participate in the study will be obtained from all patients.
The primary aims of the study is to (1) determine the diagnostic accuracy (sensitivity, specificity, and the AUC) of two rapid cognitive screening tools (AD8 and Mini-Cog) against the MoCA in the older surgical population and (2) determine the prevalence of CI as detected by the cognitive screening tests (AD8, Mini-Cog, or MoCA) and to determine the prevalence of elevated plasma biomarkers associated with neurodegenerative and/or vascular diseases using plasma (pTau181 or NfL) biomarkers in those with CI as detected by the screening tools. The secondary aims are to (1) describe the distribution of plasma pTau181 or NfL biomarkers in patients meeting the CI criteria by the AD8, Mini-Cog, or MoCA, (2) compare the trajectory of patient-reported outcomes at baseline, 30-, and 90-day post-surgery in patients with or without CI as detected by the cognitive screening tests, and (3) compare clinical outcomes in patients with or without CI as detected by the cognitive screening tests. The study consists of four consecutive time points, including one preoperative assessment and three postoperative assessments occurring during participants' hospital stay and at 30- and 90-day post-surgery. In the preoperative assessment 1-30 days before their scheduled surgery, patients will be asked to complete the AD8, Mini-Cog, MoCA and the STOP-Bang Questionnaire in-person. If a patient screens positive on one or more of the three cognitive screening tools, they will have blood drawn for pTau181 and NfL bioassay analysis. Additionally, patients will be asked to complete the following assessments via an online survey or over the telephone prior to their scheduled surgery: WHODAS-2.0 (World Health Organization Disability Assessment Schedule 2.0), 5-item FRAIL Questionnaire, PHQ-4 (4-Item Patient Health Questionnaire for Anxiety and depression), VAS (visual analog scale) pain, SQS (Single Item Sleep Quality Scale), and a single question on QoL (quality of life). The first postoperative time point will occur during participants' stay at the hospital in which postoperative delirium (POD), postoperative complications, length of stay (LOS), and discharge destination will be assessed. At 30- and 90-day postoperatively, chart review will be performed to assess clinical outcomes, such as postoperative complications, all-cause mortality, and hospital readmission. Patient-reported outcomes, including WHODAS 2.0, 5-item FRAIL Questionnaire, PHQ-4, VAS pain, and QoL, will also be assessed through an online survey or over the telephone. ;
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NCT04850833 -
Post-operative Functional Disability in Unrecognized Cognitive Impairment (POF) Study
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